Medical Self-management Research Articles

Health Technology Assessment for In Silico Medicine: Social, Ethical and Legal Aspects.

The application of in silico medicine is constantly growing in the prevention, diagnosis, and treatment of diseases. These technologies allow us to support medical decisions and self-management and reduce, refine, and partially replace real studies of medical technologies. In silico medicine may challenge some key principles: transparency and fairness of data usage; data privacy and protection across platforms and systems; data availability and quality; data integration and interoperability; intellectual property; data sharing; equal accessibility for persons and populations. Several social, ethical, and legal issues may consequently arise from its adoption. In this work, we provide an overview of these issues along with some practical suggestions for their assessment from a health technology assessment perspective. We performed a narrative review with a search on MEDLINE/Pubmed, ISI Web of Knowledge, Scopus, and Google Scholar. The following key aspects emerge as general reflections with an impact on the operational level: cultural resistance, level of expertise of users, degree of patient involvement, infrastructural requirements, risks for health, respect of several patients’ rights, potential discriminations for access and use of the technology, and intellectual property of innovations. Our analysis shows that several challenges still need to be debated to allow in silico medicine to express all its potential in healthcare processes.

Assessing a digital peer support self-management intervention for adults with serious mental illness: feasibility, acceptability, and preliminary effectiveness

Objective To assess the feasibility, acceptability, and preliminary effectiveness of digital peer support integrated medical and psychiatric self-management intervention (“PeerTECH”) for adults with a serious mental illness. Methods Twenty-one adults with a chart diagnosis of a serious mental illness (i.e., schizophrenia, schizoaffective disorder, bipolar disorder, or treatment-refractory major depressive disorder) and at least one medical comorbidity (i.e., cardiovascular disease, obesity, diabetes, chronic obstructive pulmonary disease, hypertension, and/or high cholesterol) aged 18 years and older received the PeerTECH intervention in the community. Nine peer support specialists were trained to deliver PeerTECH. Data were collected at baseline and 12-weeks. Results This pilot study demonstrated that a 12-week, digital peer support integrated medical and psychiatric self-management intervention for adults with serious mental illness was feasible and acceptable among peer support specialists and patients and was associated with statistically significant improvements in self-efficacy to manage chronic disease and personal empowerment. In addition, pre/post non-statistically significant improvements were observed in psychiatric self-management, medical self-management skills, and feelings of loneliness. Conclusions This single-arm pre/post pilot study demonstrated preliminary evidence peer support specialists could offer a fidelity-adherent digital peer support self-management intervention to adults with serious mental illness. These findings build on the evidence that a digital peer support self-management intervention for adults with serious mental illness designed to improve medical and psychiatric self-management is feasible, acceptable, and shows promising evidence of improvements in clinical outcomes. The use of technology among peer support specialists may be a promising tool to facilitate the delivery of peer support and guided evidence-based self-management support. People with serious mental illness (SMI; defined as individuals diagnosed with schizophrenia spectrum disorder, bipolar disorder, or treatment-refractory major depressive disorder) are increasingly utilizing peer support services to support their health and recovery. Peer support is defined as shared knowledge, experience, emotional, social, and/or practical assistance to support others with similar lived experiences (Solomon, 2004). Most recently the definition also includes the provision of evidence-based peer-supported self-management services (Fortuna et al., 2020). Mental health peer support can augment the traditional mental health treatment system through providing support services to maintain recovery between clinical encounters (Solomon, 2004) and is classified by the World Health Organization as an essential element of recovery (World, Health, and Organization, About social determinants of health, 2017).

Arabic translation, cultural adaptation, and pilot-testing of multimorbidity self-management self-efficacy scales.

This study aimed to translate to Arabic language and culturally adapt the Self-Efficacy for Managing Chronic Diseases Scale (SEMCD) and The Perceived Medical Condition Self-Management Scale (PMCSMS). The translation of the two scales was conducted according to the framework by Beaton et al. Then, these scales were tested in a cross-sectional correlational study with 85 Arabic-speaking participants with multimorbidities in Qatar. Psychometric tests to assess the reliability and validity of the translated scales were done. The internal consistency reliability (α) for the Arabic version of both PMCSMS and SEMCD scales was 0.953 and 0.949, respectively. Correlation coefficient (r) used to assess convergent validity between the PMCSMS and the SEMCD was 0.76 (p < 0.5). Number of morbidities negatively correlated with scores of self-management self- efficacy scores of the PMCSMS and the SEMCD (r = -0.50 and -0.51, respectively). The translated PMCSMS and SEMCD are valid and reliable scales that can be used by researchers and healthcare providers to assess levels of self-efficacy among individuals with multimorbidities. The translated scales can be employed in research or interventional programmes that aim to improve self-management or self-efficacy among individuals with multimorbidities.

Self-management perspectives of elderly patients with multimorbidity and practitioners\xa0- status, challenges and further support needed?

BackgroundPatients with multimorbidity (here defined as three or more chronic conditions) require constant treatment and care. Furthermore, they have to manage their health and diseases in daily life. Offering support to patients’ medical self-management is an important task of primary care. The aim of this study was to explore, what further support is needed from the perspective of patients’ and primary care practitioners.MethodsA qualitative study using individual semi-structed interviews with 17 patients with multimorbidity and 7 practitioners (4 primary care physicians and 3 practice assistants) was conducted in Germany. Data were audio-recorded, pseudonymised and transcribed verbatim. Data analysis was performed using qualitative content analysis to structure data into themes and subthemes. All data were managed and organised in MAXQDA.ResultsThe three broad themes: current status, challenges and further support emerged. Patients reported on unfulfilled needs regarding role or emotional management, like coping with loneliness, loss of independence and, changing habits. The importance of social contact was highlighted by patients and practitioners. Patients articulated further support from their primary care practitioners on coping with the disease. Practitioners’ wished for further support in aspects of social participation, public transport, and community resources.ConclusionChallenges regarding self-management of elderly patients with multimorbidity may be addressed by harnessing social support and community initiatives.

Advancing the Science of Recovery: The Utility of the Recovery Assessment Scale in the Prediction of Self-Directed Health and Wellness Outcomes in Adults with a Diagnosis of a Serious Mental Illness.

Adults with serious mental illness commonly experience comorbid chronic physical conditions and experience a reduced life expectancy of 10-25 years compared to the general population (Saha et al. in Arch Gen Psychiatry 64(10):1123-31.2007; Hayes et al. inActa Psychiatr Scand 131(6):417-25.2015; Walker et al. in JAMA Psychiatry 72(4):334-41.2015). Dimensions of personal recovery may have real-world implications that extend beyond functional and mental health outcomes to impact the self-directed health and wellness of adults with serious mental illness. This study examined the predictive utility of the Recovery Assessment Scale with respect to medical self-efficacy, self-management, psychiatric symptoms, and community functioning for adults with serious mental illness. Data were derived from a secondary analysis of baseline and 10-month data collected from a randomized control trial with adults aged 18 years and older with a diagnosis of bipolar disorder, schizoaffective disorder, schizophrenia, or major depressive disorder (N=56). A linear regression was conducted to examine the predictive value of total baseline RAS scores on self-efficacy at 10 months while controlling for study group. This model significantly predicted self-efficacy (F (2, 53) = 13.28, p < .001) and accounted for 36.1% of the variance. Total baseline RAS scores significantly predicted self-efficacy (β = 059, p < .001); specifically, higher baseline RAS scores were associated with greater self-efficacy. A greater degree of recovery may facilitate greater medical self-efficacy in managing chronic disease in people diagnosed with a serious mental illness. Future intervention approaches may consider recovery-focused therapeutic targets such as peer support to promote self-efficacy to manage chronic diseases in people with serious mental illness.

Effects of self-management education programmes on self-efficacy for osteoarthritis of the knee: a systematic review of randomised controlled trials

BackgroundEnhancing self-efficacy to manage symptoms and functions is an important aspect of self-management for patients with knee osteoarthritis (OA). Many reports have investigated the effects of self-management education programmes for arthritis patients. However, a study that exclusively focuses on patients with OA in the same joints is required to clarify the effects of self-management programmes because individuals with knee OA experience physical and psychological difficulties different from those experienced by individuals with other arthritis diseases. Furthermore, previous studies have reported a wide range of delivery styles of self-management education programmes. This systematic review aimed to evaluate the effects of group-based and face-to-face self-management education programmes conducted by health professionals targeting self-efficacy for knee OA exclusively.MethodsThe MEDLINE, CENTRAL, EMBASE, CINAHL, Web of Science, and PEDro databases were searched to identify quantitative measures used in randomised controlled trials (RCTs) to assess the effects of self-management education programmes targeting self-efficacy in patients with knee OA. We included studies in which medical professional-delivered self-management education programmes were conducted in a group-based and face-to-face manner in community or outpatient settings.ResultsSeven RCTs from five countries were included in this review. Our retrieved studies included various types of self-management education programmes such as cognitive behavioural counselling, pain management education, physical education, weight management education, and arthritis self-efficacy management education, and control arms. They assessed various aspects of self-efficacy, including pain, physical function, arthritis symptoms excluding pain, weight management, mobility, and self-regulation. The total score of the Arthritis Self-Efficacy Scale was also measured. Some studies have reported beneficial effects of group-based and face-to-face self-management education programmes on self-efficacy for management of pain and other symptoms and for self-regulatory, knee OA. However, the results of the included studies were varied and inconsistent.ConclusionsThe current review only included seven studies, and there was a wide range of clinical heterogeneity among these studies. Thus, the effects of group-based and face-to-face self-management education programmes conducted by health professionals on self-efficacy for knee OA exclusively are inconclusive to date. Therefore, high-quality studies are required to provide significant information on clinicians, patients, and healthcare professionals in the future.

Piperazine sulfonamides as DPP-IV inhibitors: Synthesis, induced-fit docking and in vitro biological evaluation.

Diabetes mellitus is a chronic illness that needs persistent medical attention and continuous patient self-management to avoid acute complications. Dipeptidyl peptidase-IV (DPP-IV) inhibitors minimize glucagon and blood glucose levels by increasing the incretin levels, glucagon-like peptide (GLP-1) and glucose-dependent insulinotropic poly-peptide (GIP), leading to insulin secretion from pancreatic beta cells. In the present study, nine 1,4-bis(phenylsulfonyl) piperazine derivatives 1a-i were synthesized and identified using 1H NMR, 13C NMR, MS and IR spectroscopies. These compounds were tested in vitro and showed inhibitory activity ranging from 11.2 to 22.6 % at 100 µmol L-1 concentration. Piperazine sulfonamide derivatives were found to be promising DPP-IV inhibitors, where the presence of electron-withdrawing groups such as Cl (1a-c) improved the activity of the compounds more than electron-donating groups such as CH3 ( 1d-f) at the same position. Additionally, meta-substitution is disfavored (1b, 1e, 1g). Induced-fit docking studies suggested that the targeted compounds 1a-i occupy the binding domain of DPP-IV and form H-bonding with the backbones of R125, E205, E206, F357, K554, W629, Y631, Y662 and R669.

Transition readiness among adolescents with rare endocrine conditions.

ObjectiveAdolescents and young adults (AYA) with common endocrine disorders show a high dropout (up to 50%) after the transfer from paediatric to adult endocrinology. Little is known about transition readiness in rare endocrine conditions (rEC). This study aims to assess medical self-management skills (SMS) among AYA with rEC in relation to age and gender, in order to understand dropout and increase transition readiness.DesignCross-sectional study using web-based medical self-management questionnaires.MethodsQuestionnaires consisting of 54 questions in seven domains were filled out by the adolescents before the first shared appointment with both paediatric and adult endocrinologist.ResultsFifty-seven patients (median age 17 years, 25/57 females) participated and generally scored well on most items. However, one out of seven did not know the name of their disorder, one sixth of the glucocorticoid users did not know that dose should be adapted in case of illness or surgery, over one-fifth had never ordered their repeat prescriptions themselves and two-thirds had never had a conversation alone with their doctor.ConclusionsSeveral SMS among patients with rEC are insufficient, with regard to medical knowledge, practical skills and communication. As SMS are only weakly related to non-modifiable factors, such as age and gender, we recommend focussing on other factors to increase transition readiness. The timing, amount and ‘mode’ of medical information should be individualised. Transition checklists should be used to detect shortcomings in practical skills and communication, which can subsequently be trained with the help of parents, caregivers and/or e-technology.

Older Adult Peer Support Specialists' Age-Related Contributions to an Integrated Medical and Psychiatric Self-Management Intervention: Qualitative Study of Text Message Exchanges.

BackgroundMiddle-aged and older adults with mental health conditions have a high likelihood of experiencing comorbid physical health conditions, premature nursing home admissions, and early death compared with the general population of adults aged 50 years or above. An emerging workforce of peer support specialists aged 50 years or above or “older adult peer support specialists” is increasingly using technology to deliver peer support services to address both the mental health and physical health needs of middle-aged and older adults with a diagnosis of a serious mental illness.ObjectiveThis exploratory qualitative study examined older adult peer support specialists’ text message exchanges with middle-aged and older adults with a diagnosis of a serious mental illness and their nonmanualized age-related contributions to a standardized integrated medical and psychiatric self-management intervention.MethodsOlder adult peer support specialists exchanged text messages with middle-aged and older adults with a diagnosis of a serious mental illness as part of a 12-week standardized integrated medical and psychiatric self-management smartphone intervention. Text message exchanges between older adult peer support specialists (n=3) and people with serious mental illnesses (n=8) were examined (mean age 68.8 years, SD 4.9 years). A total of 356 text messages were sent between older adult peer support specialists and service users with a diagnosis of a serious mental illness. Older adult peer support specialists sent text messages to older participants’ smartphones between 8 AM and 10 PM on weekdays and weekends.ResultsFive themes emerged from text message exchanges related to older adult peer support specialists’ age-related contributions to integrated self-management, including (1) using technology to simultaneously manage mental health and physical health issues; (2) realizing new coping skills in late life; (3) sharing roles as parents and grandparents; (4) wisdom; and (5) sharing lived experience of difficulties with normal age-related changes (emerging).ConclusionsOlder adult peer support specialists’ lived experience of aging successfully with a mental health challenge may offer an age-related form of peer support that may have implications for promoting successful aging in older adults with a serious mental illness.

Depressive disorders in Thai medical students: an exploratory study of institutional, cultural, and individual factors.

ObjectivesThis exploratory qualitative study conducted among Thai medical students aimed to investigate factors related to the development of medical students' depression and how these factors interact in contributing to depressive disorders. MethodsForty-three undergraduate medical students of the six-year Doctor of Medicine program were identified as having moderate to severe depression on an annual depression screening. From these, eighteen students agreed to participate in individual in-depth interviews. Transcriptions of the interviews were analyzed by independent reviewers using a thematic analysis approach. ResultsAmong 43 participants screened as having moderate-to-severe depression, major depressive disorder and adjustment disorder were 9.3% and 14.0%, respectively. Reported factors related to medical students' disorders were personal vulnerabilities, medical educational administration, academic achievement, learning environment, intrinsic motivation, self-care and self-management, relationship, and community. In particular, lack of social support and relationship problems were mentioned among those with more severe and persistent symptoms. Protective factors were social support, positive relationships, a growth mindset, spiritual and mindfulness practices, and an adequate mentoring program. ConclusionsMedical students' depression and suicidal ideations are significant concerns in Thai medical education. Besides personal vulnerabilities, high expectations, the value placed on academic achievement, and relationship problems can precipitate the onset of depressive disorders, if not being properly addressed. The 4P framework of predisposing, precipitating, perpetuating, and protective factors are suggested to understand the onset and development of students' depressive disorders and to identify targets for institutional and educational intervention.

Older Peer-Delivered and Smartphone-Supported Integrated Medical and Psychiatric Self-Management Intervention

PeerTECH is older peer-delivered and technology-support integrated medical and psychiatric self-management intervention developed by older adult peer support specialists. Older adult peer support specialists are older adults with a lived experience of a mental health condition, who are trained and accredited to provide support services to others with similar conditions. A pre/post trial by our group has shown PeerTECH is associated with statistically significant improvements in self-efficacy for managing chronic disease and psychiatric self-management skills. This presentation will discuss the feasibility and potential effectiveness of a 3-month pre/post study with older adults with SMI. We will discuss the potential effectiveness of PeerTECH with older adults with SMI related to loneliness, distress, and medical and psychiatric self-management. in conclusion, we will discuss the main and interactive effects of loneliness and factors linked to mortality.

Older Adult Peer Specialists’ Role in Reducing Loneliness Among People With Mental Health Conditions

PeerTECH is a peer-delivered and technology-support integrated medical and psychiatric self-management intervention developed by peers. A pre/post trial by our group has shown PeerTECH is associated with statistically significant improvements in self-efficacy for managing chronic disease and psychiatric self-management skills. This presentation will discuss the feasibility and potential effectiveness of using ecological momentary assessments (EMA) with older adults with mental health conditions to allow us to recognize early signs of loneliness and intervene as early as possible in real-world settings. EMA involves repeated sampling of an individual’s behaviors and experiences in real time, real-world environments on the smartphone application. Then, we will discuss the main and interactive effects of loneliness and factors linked to mortality. In conclusion, we will discuss potential effectiveness of PeerTECH with older adults with SMI.

The Importance of Psychiatric Rehabilitation Services During and After the COVID-19 Pandemic.

The Importance of Psychiatric Rehabilitation Services During and After the COVID-19 Pandemic.

637-P: Factors Related to Recruitment and Retention of Patients into Diabetes Group Visits

Background: Diabetes is a chronic disease requiring medical treatment and self-management. Group visits (GVs) are one way to deliver care and provide self-management education to patients with diabetes. While studies have examined the impact of GVs on clinical outcomes, no study to date has examined factors related to recruitment and retention of patients in diabetes GVs. Methods: We examined the association between patient characteristics and GV attendance of 83 patients enrolled in a GV intervention in six Midwestern FQHCs in an ongoing cluster randomized trial. Patients with uncontrolled type 2 diabetes (A1C &amp;gt;8%) who were seen in clinic in the past year were eligible. Linear mixed models were used to evaluate associations between retention of patients and race, language, comorbidities burden, diabetes empowerment score, diabetes distress score, diabetes social support, and duration of diagnosis. A Chi-squared analysis was performed to compare enrolled and unenrolled patients and test for association with patient recruitment method. Results: Of 280 eligible patients reached by FQHCs, 44% (24/55) of patients contacted in person were recruited into the study, compared to 25% (56/225) of those contacted by telephone and/or mail (P=0.006). In the multivariate analysis, patients with more GV attendance were associated with higher diabetes empowerment score (P=0.03) and likely heavier comorbidities burden (P=0.08). Conclusion: In-person recruitment for group visits was more effective than recruitment by telephone or mail. Patients with more comorbidities and those who felt less empowered to manage their diabetes at baseline were most motivated to attend GVs, suggesting that patients with multiple chronic conditions who need more support in disease management may be most interested in receiving care in a group setting. This finding may be especially important for FQHC providers taking care of underserved populations who face greater barriers to self-management in traditional care settings. Disclosure A.G. Naik: None. E.M. Staab: None. J. Li: None. W. Wan: None. C.T. Schaefer: None. A. Campbell: None. M.T. Quinn: None. A.A. Baig: None. Funding Office of Minority Health (1 CPIMP171145-01-00)

English

This article aims to explore the relationship between patient empowerment and information and communication technologies (ICTs). Indeed, ICTs are considered important for increasing access to medical information and for patients’ other experiences, thereby nourishing the empowering rhetoric. The paper presents a research study conducted in Italy that focuses on the self-assessments made by online health communities (OHCs) users, subdivided in three categories, according to their level of online activity: Lurkers, occasionally active users and frequently active users. The concept of empowerment was operationalised in five issues: autonomy from doctors, involvement in medical decision-making, competence, self-management and acceptance. The results support the relationship between perceptions of empowerment and the higher level of activity played on OHCs, contributing instead to reject the idea of a generalised benefit. Moreover, the paper aims to enrich the theory of patient empowerment by adding a socio-material perspective. This helps broaden the understanding of the relationship between empowerment and ICTs by highlighting its underlying complex skein. Key words: Empowerment, self-management, information and communication technologies, online health communities, socio-material perspective, chronic disease.

Development and Validation of an Application for Follow-up of Patients Undergoing Dialysis: NefroPortátil

To develop the NefroPortatil mobile application (app) and evaluate its effects on the management of patients undergoing dialysis. The first stage of the work was the development, installation, and establishment of the instructions to use the phone app as an instrument to aid in the control of fluid and food intake of 52 patients undergoing dialysis. In the second stage, the patients were monitored for 3months and evaluated using questionnaires to measure the improvement in quality of life (Kidney Disease Quality of Life Instrument) and self-management of disease (Perceived Medical Condition Self-Management Scale) by the app. In addition, laboratory tests were performed before app use and in the first, second, and third months of its use (January to April 2018). Analysis of variance was used to analyze the laboratory data, and a paired Student's t test was used to analyze the responses to the questionnaires and as a posttest (P<.05). Among the laboratory test results, serum phosphorus levels showed a significant difference (P<.04) after the app was used. A significant improvement was observed in self-management of the disease according to the Perceived Medical Condition Self-Management Scale questionnaire (P<.03). The usability of the app reached a median score of 9.65 from a total score of10. The NefroPortatil app improved the degree of perception of self-care of patients undergoing dialysis with chronic kidney failure, in addition to favoring nutritional control.

Fact-finding survey regarding judo-related injuries of judokas in developing country.

[Purpose] The purpose of this study was to investigate sports-related injuries among judokas in Mongolia which is classified in the lower-middle income country. This study may help prevent future sports-related injuries. [Participants and Methods] We studied 75 judokas affiliated to the judo club in Ulaanbaatar, Mongolia. The questionnaire survey included questions regarding current and past judo-related injuries. [Results] Out of 75 judokas, 39% judokas had current judo-related injuries, and 25% judokas had past injuries. The injuries were most commonly located in the shoulder/clavicular, followed by that in the ankle and knee. The most frequent injury was a sprain/ligament injury, followed by a fracture and a dislocation. Seventy-three percent of current injuries and 88% of the past injuries received medical attention. Self-management was carried out for 35% of the injuries. The time lost from judo matches and training was 0–1,095 days for current injuries and 0–545 days for past injuries. [Conclusion] In this study, the injury rate for judokas was higher than that reported in previous studies. In addition, numerous severe injuries were noted. It is observed that, despite medical attention and self-management, the recovery periods are prolonged. Additionally, we believe that the judokas are unable to return to competition without problems.

Acceptability and Feasibility of a Disease-specific Patient Portal in Adolescents With Sickle Cell Disease.

To examine the acceptability, feasibility, and efficacy of a health care portal. Adolescents and young adults with sickle cell disease were taught how to use sickle cell disease conditions page in MyChart and completed questionnaires at baseline, postintervention (T2, 6 wk after baseline) and after 3 months (T3). In total, 44 participants (M age=18.82, SD=2.72) viewed an average of 58.07 pages from T1 to T2. The portal was highly accepted (90.32%). Efficacy data indicated that portal use was associated with improved patient-provider communication. Electronic portals are promising tools for improving medical self-management.

Psychosocial Interventions for Patients with Severe COPD-An Up-to-Date Literature Review.

Background and Objectives: Chronic obstructive pulmonary disease (COPD) is a life limiting condition with a long list of serious psychosocial consequences, aggravating with illness progression. In advanced stages, chronic respiratory failure often develops, which might undermine mental health and reduce activity. The study objective was to review the recent studies concerning psychosocial interventions dedicated to patients with severe COPD. Materials and Methods: The PubMed database was searched for terms, such as ‘COPD and long-term oxygen therapy, non-invasive ventilation, severe or respiratory failure’ and ‘psychological or psychosocial or mental health and intervention.’ Studies were included that described patients with stable, severe COPD and the outcomes of psychosocial interventions. Results and Conclusions: Thirty-four studies were identified and divided into four thematic groups: home medical support, exercise, self-management and mental health. The number of studies that focused on mental health preservation in severe COPD was very limited; i.e., none refer directly to those treated with respiratory failure. Improving patients’ self-efficacy gave promising effects to the acceptance of palliative care, pulmonary rehabilitation completion and mental health. Physical activity might be recommended to be included in interventions for mental health enhancement, although little is known about the role of the particular forms of exercise. An increasing beneficial use of new technologies for psychosocial interventions was noted. Psychosocial interventions applied in advanced COPD underline the roles of self-efficacy, telehealth and physical activity in physical and mental health preservation. However, all of the above elements need to be independently tested on more homogenous groups of patients and have the possible modes of their treatment analysed.

"Smartphone Medication Adherence Saves Kidneys" for Kidney Transplantation Recipients: Protocol for a Randomized Controlled Trial.

BackgroundKidney transplant recipients’ poor medication adherence and poor control of comorbidities, particularly hypertension, are risk factors for graft rejection, graft loss, and death. Few randomized controlled trials (RCTs) have been successful in improving sustained medication adherence and blood pressure control among kidney transplantation recipients. We provide rationale for an RCT evaluating a mobile health medical self-management system for kidney transplantation recipients called Smartphone Medication Adherence Saves Kidneys (SMASK).ObjectiveOur objective is to determine whether SMASK is efficacious in improving medication adherence and sustaining blood pressure control among kidney transplantation recipients with uncontrolled hypertension and poor medication adherence compared to an enhanced standard care.MethodsThis two-arm, 6-month, phase II single-site efficacy RCT will involve 80 kidney transplantation recipients. Participants will be randomly assigned to the SMASK intervention arm or control arm. SMASK includes multilevel components: automated reminders from an electronic medication tray; tailored text messages and motivational feedback, guided by the self-determination theory; and automated summary reports for providers. Evaluations will be conducted preintervention, at 3 and 6 months, and posttrial at 12 months. Specific aims are to test the hypotheses that compared to standard care, the SMASK cohort will demonstrate significantly improved changes at 3, 6, and 12 months in the primary outcome variables medication adherence (proportion with electronic monitor-derived score >0.90) and blood pressure control (proportion meeting and sustaining adherence to the Kidney Disease Improving Global Outcomes [KDIGO] guidelines for blood pressure control); the secondary outcome variables provider adherence to KDIGO guidelines, measured by timing of medication changes and changes in self-determination theory constructs; and the exploratory outcome variables estimated glomerular filtration rate, variability in calcineurin inhibitor trough levels, and proportion of patients meeting and sustaining the 24-hour ambulatory blood pressure below 130/80 mm Hg. After the 6-month evaluation, interviews with a random sample of SMASK subjects (n=20) and health care providers (n=3-5) will assess user reactions including acceptability, usability, and aids/barriers to sustainability. Data from the RCT and interviews will be triangulated to further refine and optimize SMASK and prepare for a multisite effectiveness RCT.ResultsThe SMASK project received funding from National Institute of Diabetes and Digestive and Kidney Diseases in June 2016, obtained institutional review board approval in April 2016, and began data collection in July 2016. As of July 2018, we completed enrollment with a total of 80 participants.ConclusionsThis study will provide data regarding the efficacy of SMASK to improve medication adherence and blood pressure control in a cohort of hypertensive kidney transplant recipients. An efficacious SMASK intervention will pave the way for a larger, multicenter, effectiveness RCT powered sufficiently to evaluate clinical events in a real-world setting and with the potential to demonstrate improved outcomes at lower cost than standard care.International Registered Report Identifier (IRRID)DERR1-10.2196/13351